Category: Actualités VVR Medical

L’adoption d’Ozempic en Chine : implications pour la santé publique et le contrôle de l’obésité

L’adoption d’Ozempic en Chine : implications pour la santé publique et le contrôle de l’obésité

En 2022, 38 % de la population était en surpoids et 8 % était obèse. La Chine connaît une hausse rapide de l’obésité. Ce phénomène inquiète les autorités sanitaires et a suscité une réaction du public. Parmi les nombreuses techniques et régimes à la mode pour perdre du poids, on observe un essor des médicaments spécialisés tels que l’Ozempic (semaglutide).

Les Médicaments GLP-1 et ozempic

L’Ozempic, produit par Novo Nordisk sous le nom de NovoCare en Chine, appartient à la classe des médicaments GLP-1. Initialement approuvé pour le diabète de type 2, son champ d’action a récemment été étendu au traitement de l’obésité. Ces médicaments agissent en mimant une hormone qui régule la glycémie et aide à supprimer l’appétit, ce qui les rend utiles pour la perte de poids.

Avancées réglementaires et marché

En 2024, la NMPA a approuvé l’Ozempic pour la gestion du poids à long terme, une première pour les médicaments GLP-1 dans le pays. Cette approbation est vue comme une réponse à l’augmentation des taux d’obésité. Parallèlement, le tirzepatide d’Eli Lilly a également été autorisé, indiquant une ouverture du marché à ces traitements. Pour l’instant, les deux entreprises représentent ensemble environ 94% des ventes totales de médicaments GLP-1 en Chine.

Interrogations et avis partagés

Malgré la popularité de l’Ozempic et des autres médicaments GLP-1, des inquiétudes subsistent concernant leurs effets secondaires et leur coût élevé, ce qui pourrait limiter leur adoption. De plus, les réseaux sociaux reflètent des opinions partagées, oscillant entre l’enthousiasme pour leur efficacité et la méfiance due aux expériences négatives.

Perspectives pour les médicaments GLP-1 sur le marché chinois

La forte demande et les préoccupations de santé publique continuent de stimuler l’intérêt pour les médicaments GLP-1. Les acteurs du secteur pharmaceutique chinois ont initié leurs propres recherches et développement pour mettre au point des médicaments GLP-1. Actuellement, le beinaglutide de Shanghai Benemae, le premier médicament GLP-1 développé en Chine, fait l’objet d’essais cliniques pour le traitement de la perte de poids, et son approbation potentielle est attendue prochainement.  Les entreprisesHengrui Medicine

, Gan & Lee Pharmaceuticals et Haosen Pharmaceuticals investissent également massivement dans la recherche et le développement pour mettre sur le marché des traitements à base de GLP-1.

 

Source : 36Kr, Designed by daxue consulting, Des médicaments GLP-1 contre l’obésité en cours de recherche en Chine

Avec l’expiration prochaine des brevets et l’émergence de produits locaux potentiellement moins coûteux, le marché pourrait devenir plus compétitif et accessible. La transparence sur les effets et les résultats à long terme sera cruciale pour gagner la confiance des consommateurs.

Pour lire l’article complet et obtenir plus de détails, consultez le dossier de Daxue : Behind the burgeoning popularity of weight loss drug Ozempic in China

VVR Medical et Daxue Consulting sont spécialisés dans l’accompagnement stratégique et opérationnel des entreprises du secteur médical sur le marché chinois. N’hésitez pas à nous contacter à l’adresse contact@vvrmedical.com pour recevoir les conseils et le soutien de nos experts dans votre projet.

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Regenerative Medicine, the Coming Revolution of Cancer Treatment

Regenerative Medicine, the Coming Revolution of Cancer Treatment

In the relentless pursuit of cancer treatment, one field is poised to revolutionize our approach: regenerative medicine. This isn’t just another incremental advance; it is a paradigm shift in how we understand and treat cancer. This article will guide you through the intricacies of regenerative medicine, its transformative research, and why it could be the cornerstone for cancer treatment in both developed and developing nations. For medical companies eyeing international expansion, particularly in China, this is an innovation you cannot afford to ignore.

What is Regenerative Medicine?

Regenerative medicine is a multidisciplinary field that aims to repair, replace, or regenerate damaged tissues and organs. It’s not a new concept; the idea has been around for decades. However, recent advancements in technology and research have propelled it into the limelight.

The Science Behind It

At the core of regenerative medicine is the manipulation of cells and tissues to treat diseases. This involves a range of scientific disciplines, including biology, chemistry, and engineering. Researchers are learning how to harness the body’s innate ability to heal itself, amplifying or directing these processes through scientific intervention.

Types of Regenerative Medicine

The field is broadly categorized into four types:

Tissue Engineering: Creating functional tissues in labs that can be implanted into patients.

Cellular Therapies: Using cells, often stem cells, to repair damaged tissues directly.

Medical Devices and Artificial Organs: Devices that can temporarily or permanently take over the function of an organ.

Combinations of the Above: Innovative treatments that combine elements of tissue engineering, cellular therapies, and medical devices.

The Ongoing Research and Methods

The field of regenerative medicine is bustling with research, much of which is focused on cancer treatment. From academic labs to pharmaceutical giants, the race is on to develop therapies that are both effective and safe. Recent articles highlight the significant challenges in treating cancer and how regenerative medicine is participating in the development of novel cancer treatments.

Cutting-Edge Methods

Several methods are at the forefront of this research:

Stem Cell Therapy: Utilizing stem cells to replace damaged cells. This is particularly promising for blood-related cancers like leukemia. Researchers are currently exploring stem cells that underlie various types of cancers.

Gene Editing: Techniques like CRISPR are being used to modify genes, potentially correcting mutations that lead to cancer.

3D Bioprinting: The creation of cellular structures using 3D printing technology, which can be used for testing drug responses or even creating replacement tissues.

Case Studies and Clinical Trials

Numerous clinical trials are underway to test the efficacy of these methods. For instance, CAR-T cell therapy, a type of stem cell therapy, has shown remarkable results in treating certain types of lymphoma.

The Revolution in Cancer Treatment

The efficacy of regenerative medicine therapies is often higher than traditional methods, with fewer side effects. Patients experience a more personalized treatment, tailored to their specific needs. For example, stem cells have the potential to treat numerous genetic and degenerative disorders, including cancers.

Importance in Developing Countries

The potential of regenerative medicine extends beyond the borders of developed nations. Developing countries, often burdened with limited healthcare infrastructure, can benefit immensely from these therapies. They offer a cost-effective and scalable solution, making quality cancer treatment accessible to a broader population.

Regulatory Landscape: EU vs China

When it comes to regulations, the European Union and China have different approaches. The EU has stringent regulations to ensure the safety and efficacy of these therapies. China, on the other hand, has been more aggressive in adopting regenerative medicine, often fast-tracking research and clinical trials. For instance, more than 450 cell therapy clinical trials are currently ongoing in China. This has made the country a burgeoning hub for regenerative medicine research.

Pioneering the Future of Cancer Treatment

Regenerative medicine is not just a scientific curiosity; it’s a transformative approach that is redefining the landscape of cancer treatment. Its potential is universal, offering hope to patients in both developed and developing countries. For medical companies looking to expand internationally, particularly in China, this is an area ripe for investment and innovation.

For European innovators in therapeutics, medical technology and diagnostics targeting the Chinese market, VVR Medical offers comprehensive market entry services. With over 15 years of hands-on experience in human healthcare in China, VVR Medical provides a unique, all-encompassing, personalized approach to accelerate your China market entry. From strategic diagnosis to implementation, VVR Medical assists you in clearing regulatory hurdles, identifying necessary resources, and preparing for efficient commercialization, setting you on the path to success in this burgeoning market.

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The potential of biomarkers for early diagnosis

The potential of biomarkers for early diagnosis

Imagine a world where debilitating diseases like cancer, Alzheimer’s, or heart ailments can be identified before they manifest symptoms, allowing for treatments that are not just less invasive but also significantly more effective. The technology that holds the promise to turn this vision into reality is already among us – it’s called biomarkers. By diving into this article, you’re taking the first step to understanding how biomarkers are revolutionizing the landscape of healthcare, especially in the realm of early diagnosis.

Unveiling the Power of Biomarkers

This section aims to unfold the transformative potential of biomarkers and their use in early diagnosis by explaining their unique diagnostic characteristics.

What are Biomarkers?

Biomarkers, or biological markers, are measurable indicators of some biological state or condition. They can be molecules, cells or cell fragments, genes, or characteristics observed through medical imaging. Biomarkers exist in various categories, primarily diagnostic, prognostic, and predictive. Diagnostic biomarkers identify whether a disease is present, prognostic biomarkers forecast the disease’s progression, and predictive biomarkers anticipate how a disease will respond to treatment.

The Revolutionary Potential for Early Diagnosis

Early diagnosis is an undisputed game-changer in healthcare. When diseases are identified in their initial stages, treatment outcomes are often significantly better, and healthcare costs can be reduced. Recent research has propelled biomarkers into the spotlight as a tool for early diagnosis. For instance, liquid biopsy, a non-invasive test, can now detect circulating tumor DNA in blood samples, providing a revolutionary way to identify early-stage cancer.

Studies have shown the increasing reliability of biomarkers in early diagnosis. For instances, in cardiovascular diseases, a high level of troponin – a type of protein – serves as an early warning sign of a heart attack; in cancer, the detection of circulating progastrin in the bloodstream has demonstrated its relevance in early diagnosis of various types of solid tumors. The utilization of such biomarkers has been instrumental in reducing mortality rates from heart attacks.

Methodologies and Challenges

In the quest to personalize medicine and revolutionize diagnostic procedures, biomarker discovery and successful clinical exploitation stands at the forefront, offering a glimpse into a future where treatment is tailored to the individual’s unique biological signature. The very advancements that promise a new era of medicine also beckon a host of ethical, financial, and technical conundrums.

Research Methodologies

Various methodologies are employed in biomarker discovery and validation. Some of the cutting-edge techniques include genomics, proteomics, and metabolomics.

Genomics: The entire genetic blueprint of an organism is the focus of this domain, with an exploration into how genes interact and function.

Proteomics: This area examines the structure and function of proteins, which are the products of gene expression.

Metabolomics: In this area, the emphasis is on the examination of small molecules, termed as metabolites, which originate from the actions of both genes and proteins.

High-throughput technologies like next-generation sequencing have revolutionized these fields, enabling the identification of new biomarkers at a faster rate. Multi-omics technologies encompass genomics, transcriptomics, proteomics, and metabolomics. These technologies act as efficient and effective tools for disease diagnosis, management, monitoring, treatment, and the discovery of novel biomarkers.

Challenges and Influential Factors

While the promise of biomarkers is immense, there are challenges that influence their widespread adoption. Ethical considerations, such as the privacy and security of genetic data, are a constant concern. Additionally, the cost factor cannot be ignored. Advanced tests can be expensive, which raises questions about accessibility, especially in developing countries.

The Global Landscape – From EU Regulations to Implications for Developing Countries

As we navigate the evolving landscape of global health diagnostics, biomarker regulation stands as a pillar of quality and safety. This section provides a comprehensive overview of the stringent regulatory frameworks of the European Union and their far-reaching implications for developing nations.

EU Regulations

The European Union has stringent regulations for the approval of biomarkers. All biomarkers must undergo rigorous clinical trials, most often conducted on the European soil, to establish their reliability and efficacy. The EU’s In Vitro Diagnostic Regulation (IVDR) serves as a comprehensive framework governing the approval and monitoring of in vitro diagnostic medical devices, including biomarkers.

Implications for Developing Countries

The stringent nature of EU regulations could serve as a benchmark for developing countries eager to adopt biomarker technology. However, challenges like inadequate healthcare infrastructure, low awareness, and limited financial resources make the situation complex. Despite these obstacles, the potential benefits of early diagnosis through biomarkers could be transformative for healthcare systems in these regions.

Conclusion: Toward a New Frontier in Early Diagnosis

Biomarkers have emerged as a potent tool in the world of healthcare, offering promising avenues for early diagnosis that can lead to more effective treatments and better patient outcomes. As we have seen, the European Union has set rigorous standards for the adoption of this technology, which could serve as a template for other nations, including those with developing economies. Yet, it is worth noting that countries like China are rapidly advancing in this sector (both technology-wise and cost-wise, with affordable full-genome sequencing devices adapted to single-patient diagnosis becoming a reality as we speak), with the potential to contribute to global healthcare by setting new benchmarks in the utilization of biomarkers for early diagnosis.

For European medical technology and diagnostic innovators looking to expand into the Chinese market, VVR Medical offers unparalleled expertise and assistance. Leveraging a deep understanding of both European and Chinese regulatory landscapes, VVR Medical provides services that range from strategic diagnosis to commercial development and supply chain management. By partnering with VVR Medical, businesses can navigate the complexities of the Chinese healthcare ecosystem, thereby securing and strengthening their foothold in one of the world’s most lucrative and fast-growing markets.

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Advancing Frontiers: The Rise of Minimally Invasive Surgical Techniques

Advancing Frontiers: The Rise of Minimally Invasive Surgical Techniques

In the realm of medical science, the evolution from open surgical procedures to minimally invasive surgical techniques marks a significant stride towards better patient care and enhanced operational efficiency. This shift not only epitomizes the advancement of medical technology but also mirrors the relentless pursuit of reducing surgical invasiveness and the associated risks. The focus of this article is to unravel the various minimally invasive surgical techniques currently in use, the ongoing research aimed at honing these methods, and the global implications of such medical innovations.

Unveiling Modern Techniques

The scope of minimally invasive surgical techniques is continuously expanding, thanks to relentless innovations in medical technology. Here’s a glance at some of these modern techniques.

Laparoscopy

Known as keyhole surgery, laparoscopy is widely used in gastrointestinal, gynecological, and urological surgeries. Recent advancements include the integration of artificial intelligence (AI) and robotic assistance, enhancing surgical precision, but also Single-Incision Laparoscopic Surgery (SILS), Natural Orifice Transluminal Endoscopic Surgery (NOTES), and telementoring, which have shown promise in bettering surgical outcomes and patient recovery times. The global market for laparoscopy devices is projected to grow at a CAGR of 6.5% from 2020 to 2030, reflecting the escalating adoption of this technique.

Endoscopy

Utilizing an endoscope, this technique allows visualization of internal body cavities. Surgical polarimetric endoscopy, a recent advancement, has been employed for the detection of laryngeal cancer. The year 2023 saw the launch of Olympus’s EVIS X1™ endoscopy system, marking a substantial stride in endoscopic technology​. The convergence of artificial intelligence and robotics with endoscopy is a trend to watch, as these technologies are driving further advancements in this domain.

Robotic Surgery

Robotic surgery, once a futuristic idea, has become a reality with its application spanning across various surgical domains, including cardiothoracic, colorectal, urological (in particular with EDAP TMS’s FocalOne® robotic HIFU solution), general, gynecology, and head-and-neck surgery, driven by ongoing technological advances. The surgical robotics market, now exceeding $3 billion, is poised for significant growth, with an increased demand for Robotic-Assisted Surgery (RAS) across the globe.

Laser Surgery

Laser surgery employs beams of light to cut, remove, or cauterize tissue, and is hailed for its precision and minimal damage to surrounding tissues. Recent advancements in refractive surgery, such as the rise of Small Incision Lenticule Extraction (SMILE) and the introduction of technically competitive laser systems, mark a paradigm shift in surgical precision, efficacy, and patient outcomes​. Improvements in aesthetic laser devices, including longer dye lives and increased wavelength capacities, contribute to the enhanced precision and accuracy of laser treatment​.

These techniques, each with its unique advancements, contribute to better patient care, faster recovery times, and reduced healthcare costs, showcasing significant strides in the surgical domain.

The Spectrum of Benefits

Minimally invasive surgical techniques hold a plethora of benefits that significantly enhance both patient care and operational efficiency. Here are the key advantages underscored by recent data:

Reduced Recovery Time

Smaller incisions expedite healing, enabling patients to resume normal activities sooner, substantiated by reduced postoperative complications and shorter hospital stays.

Lesser Pain and Scarring

Patients experience less post-operative pain and minimal scarring, contributing to better cosmetic results and an improved recovery experience​.

Lower Risk of Infection

The minimized exposure of internal body structures to potential contaminants lowers the risk of post-surgical infections, aligning with improved postoperative pain control and shortened postoperative hospitalization​.

Cost-Efficiency

Quicker recovery times, lower infection risks, and shorter hospital stays contribute to lower healthcare costs, aligning with the medico-economic benefits associated with MIS​.

Trailblazing Research and Emerging Techniques

The voyage of minimally invasive surgical techniques into new horizons is steered by groundbreaking research. Here’s a glimpse into the contemporary research and emerging techniques that are pushing the boundaries.

Robotic Assistance

The symbiosis of robotics with minimally invasive surgery is escalating surgical precision and control to unprecedented levels. The advent of sophisticated robotic systems is enabling surgeons to perform complex procedures with enhanced accuracy and minimal invasiveness. Recent innovations like the reconfigured robotic arm design, faster docking to reduce operative time, and fluorescence-detection to identify structures and lesions are notable advancements in this domain. Moreover, robotic-assisted surgery has become a popular trend offering prospective benefits to patients like shorter hospital stays, earlier recovery, and less pain, along with operational benefits to surgeons.

Artificial Intelligence (AI)

AI is the torchbearer of predictive analytics and real-time decision support during surgical procedures. It is fostering a paradigm of data-driven surgery, where AI algorithms aid in enhancing surgical precision and optimizing patient outcomes. While not aimed at replacing surgeons but rather at making most use of their experience and knowledge, AI has the potential to revolutionize surgery, particularly in technical skill assessment and integration into surgical robots, which paves the way for improved preoperative planning and intraoperative guidance.

3D Visualization and Augmented Reality (AR)

3D visualization and AR are revolutionizing the way surgeons interact with medical imaging data. Technologies like the XR90 augmented reality-based surgical visualization and navigation platform combine CT imaging with live ultrasound to perform minimally invasive procedures with enhanced precision. AR technology superimposes artificial targets onto a live view of patient anatomy, offering a more intuitive understanding of anatomical structures and enhancing surgical planning and execution.

Telemedicine and Remote Surgery

The combination of telemedicine with minimally invasive surgical techniques is greatly enhancing the application range for remote surgery and consultations. Telementoring, a form of remote teaching in surgery that includes more and more 3D/AR visualization modes, enriches the training options for surgical trainees, while telemedicine addresses some barriers to surgical care, especially in low- and middle-income countries, by providing remote healthcare services.

Advanced Imaging Technologies

Cutting-edge imaging technologies are the linchpin of successful minimally invasive procedures, offering clearer and more detailed visualizations crucial for surgical success. The evolution of medical imaging systems has been rapid, with the integration of artificial intelligence, cloud-based solutions, and mobile technology revolutionizing medical imaging.

Bridging Surgical Frontiers

The significance of minimally invasive surgical techniques extends beyond the operating rooms of developed nations to developing countries where healthcare resources are often limited. Moreover, the global reverberations of advancements in minimally invasive surgery are palpable, with countries like China embracing and investing in these techniques to foster a robust healthcare ecosystem.

VVR medical, a conduit for European innovators in medical technology and diagnostics, facilitates a smooth entry and establishment in the Chinese market, accelerating China market entry through strategic diagnosis, qualification, and efficient commercialization of products and services. This symbiosis of surgical advancements and market access strategies elucidates a promising trajectory towards a global surgical landscape that is not only efficient and effective but also inclusive and progressive, steering the global healthcare community towards a horizon where surgical care is more accessible, less invasive, and profoundly impactful.

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L’Intelligence Artificielle au service du diagnostic médical : des opportunités d’expansion mondiale à découvrir

 L’Intelligence Artificielle au service du diagnostic médical : des opportunités d’expansion mondiale à découvrir

Dans le secteur dynamique de la santé, l’intelligence artificielle (IA) s’est imposée comme une force révolutionnaire, en particulier dans le domaine du diagnostic médical. En combinant la puissance d’algorithmes sophistiqués avec des connaissances cliniques, l’IA facilite les diagnostics et les rend plus rapides et plus précis.  Cela bénéficie au patient, au praticien et à l’ensemble de la chaîne de soins de santé. Pour les entreprises visionnaires, c’est l’occasion rêvée d’élargir leurs horizons au-delà des frontières nationales et de prospérer sur la scène internationale.

 

L’essence de cet article réside dans l’élucidation du potentiel de transformation de l’IA dans les diagnostics médicaux, et dans la manière dont elle peut être un catalyseur pour les entreprises qui aspirent à une expansion mondiale. Alors que les besoins en matière de soins de santé ne cessent de croître dans le monde entier, l’exploitation de l’IA peut permettre aux entreprises de relever ces défis de front, tout en respectant les réglementations spécifiques et rigoureuses des différentes régions – dont certaines sont souvent peu familiarisées avec le sujet. Ainsi, s’intéresser aux prouesses de l’IA en matière de diagnostic n’est pas simplement une exploration du progrès technologique, mais un voyage vers l’ouverture de nouvelles voies de croissance et la réalisation d’avancées significatives à l’échelle internationale concernant les soins de santé.

Naviguer dans la transformation : Exploiter l’IA pour un diagnostic d’excellence

La place de l’IA dans la reconfiguration du secteur du diagnostic médical est tout à fait remarquable. Voici un aperçu des domaines actuellement concernés et des avantages de l’IA pour les entreprises liées au domaine du diagnostic médical qui souhaitent se développer à l’international :

  • Détection et diagnostic précoces :

    • Les outils de diagnostic alimentés par l’IA sont une aubaine pour la détection précoce des maladies. Or le diagnostic précoce améliore considérablement les chances de traitement efficace et de guérison des patients. Cela est particulièrement vrai pour les pays en développement, où le diagnostic précoce est souvent la clé d’une amélioration spectaculaire de l’ensemble du système de santé et, par conséquent, de la santé des populations. The In-Vitro Diagnostics market post-Covid in China – VVR International, développement stratégique, production, sourcing, distribution…
    • Pour les diagnostics basés sur l’imagerie, grâce à la reconnaissance d’images et à l’analyse de données avancées, l’IA peut identifier des changements subtils ou des anomalies dans les images médicales bien plus tôt que l’œil humain.
  • Amélioration de la précision et de l’efficacité :

    • En réduisant le risque d’erreur humaine et en résolvant les multiples problèmes de répétabilité et de cohérence, l’IA améliore la précision des diagnostics.
    • Elle accélère également le processus de diagnostic, fluidifie le parcours du patient et garantit une intervention rapide et de meilleurs résultats pour le patient. L’IA a par exemple pu diagnostiquer des problèmes cardiaques en 15 secondes seulement, alors que la moyenne humaine est de 30 minutes à une heure.
  • Avantages potentiels pour l’expansion internationale des entreprises :

    • Répondre aux normes internationales en matière de soins de santé : Grâce à l’IA, les entreprises peuvent améliorer leurs services de diagnostic afin de satisfaire, voire de dépasser, les normes internationales en matière de soins de santé. Cela constitue un aspect essentiel pour s’implanter sur les marchés étrangers qui ont besoin d’innovations de pointe.
    • Surmonter les contraintes géographiques et de ressources : À condition que les solutions soient conçues et mises en œuvre conformément aux réglementations et aux normes applicables en matière de sécurité des données et de protection de la vie privée des patients, l’IA peut aider à transcender les barrières géographiques et les limitations des ressources en permettant des diagnostics à distance. Ces diagnostics permettent d’optimiser l’utilisation des ressources, ce qui rend l’expansion internationale plus faisable et plus durable.

L’intégration de l’IA dans les diagnostics médicaux n’ouvre pas seulement la voie à une amélioration de la prestation des soins de santé, mais aussi à un monde de possibilités pour les entreprises d’étendre leurs services à l’échelle mondiale. En s’alignant sur l’éthique mondiale des soins de santé, qui consiste à établir des diagnostics précoces et précis, les entreprises peuvent se tailler une place sur le marché international, ce qui leur confère un avantage concurrentiel considérable.

Paysage réglementaire et éthique : Se préparer aux marchés internationaux

Naviguer à travers les divers paysages réglementaires et éthiques est une condition préalable à une incursion réussie sur les marchés internationaux avec des diagnostics médicaux pilotés par l’IA. Voici quelques éléments clés à prendre en compte :

  • Comprendre les différents cadres réglementaires :

    • Il est impératif de se familiariser avec les exigences réglementaires des marchés cibles, telles que le cadre de la FDA américaine ou la loi sur l’intelligence artificielle de l’UE, afin de garantir la conformité et une entrée facilitée sur le marché. Cela est particulièrement vrai pour l’expansion vers certains pays et territoires, comme la Chine, où l’autorisation des États-Unis ou de l’UE est souvent une condition préalable à un enregistrement local réussi.
    • Engagez-vous auprès des organismes de réglementation nationaux et sollicitez les conseils d’experts en réglementation locale pour aligner vos solutions de diagnostic IA sur les cadres juridiques en vigueur. Une attention particulière doit être porter sur les réglementations concernant la sécurité des données, la confidentialité des patients ainsi que sur les conditions de transfert et d’exploitation transfrontaliers des données.

 

  • Considérations éthiques dans les diagnostics pilotés par l’IA :

    • Au-delà de la stricte conformité réglementaire et juridique, la résolution de dilemmes éthiques tels que la protection de la vie privée, les préjugés et la transparence est essentielle pour instaurer un climat de confiance avec les parties prenantes locales et les patients.
    • Établir des lignes directrices éthiques claires et documentées et veiller à ce qu’elles soient communiquées à tous les niveaux de l’organisation.

 

  • Renforcer la confiance et la crédibilité :

    • L’établissement d’une réputation en matière de pratiques éthiques et de respect de la réglementation peut renforcer la confiance des patients, des prestataires de soins de santé et des autorités locales.
    • Élaborer un système solide pour traiter les griefs et garantir la responsabilité dans les processus de diagnostic pilotés par l’IA.

Alliances stratégiques : Favoriser les partenariats mondiaux

La formation d’alliances stratégiques est la pierre angulaire d’une navigation réussie dans le paysage mondial de l’IA dans le domaine du diagnostic médical. Ces partenariats peuvent fournir des informations locales inestimables et favoriser un environnement propice à la croissance et à l’innovation. Voici quelques étapes et considérations cruciales :

  • Partenariat avec les prestataires de soins de santé et les autorités locales :

    • Établissez des partenariats avec les fournisseurs de soins de santé et les autorités locales afin de mieux comprendre les écosystèmes de soins de santé locaux, les paysages réglementaires et les besoins des patients. Des adaptations ciblées afin de répondre à ces besoins peuvent considérablement améliorer l’acceptation locale et l’impact de vos solutions de diagnostic pilotées par l’IA.
  • S’engager dans la recherche et le développement collaboratifs :

    • Engagez-vous dans la recherche et le développement en collaboration avec des institutions locales, par le biais d’une recherche clinique ad hoc et publiable qui permet aux praticiens de se familiariser avec vos solutions, ce qui vous aidera à innover et à affiner les solutions de diagnostic IA en les alignant sur les défis locaux en matière de soins de santé et sur les normes mondiales.
  • Exemples d’expansions internationales réussies :

Conclusion : Saisir l’opportunité mondiale : Vos prochaines étapes

Le panorama de l’IA dans le domaine du diagnostic médical offre un terrain fertile aux entreprises qui aspirent à étendre leur champ d’action à l’échelle mondiale. En exploitant le potentiel de transformation de l’IA, en comprenant les divers cadres réglementaires, en contribuant à la formation des organismes réglementaires locaux sur les avancées et les avantages de vos solutions, en formant des alliances stratégiques et en s’inspirant d’exemples de cas réussis, les entreprises peuvent naviguer dans les complexités des marchés internationaux.

VVR Medical accompagne l’innovation

VVR Medical est une passerelle pour les innovateurs européens en matière de technologie médicale et de diagnostic qui s’intéressent au vaste marché chinois. En effet, ce marché combine de manière unique un besoin massif de nouveaux paradigmes de diagnostic pour faire face aux défis de santé très étendus, un fort attrait pour l’innovation de pointe et un régulateur flexible qui est prêt à interagir avec vous à tous les stades de votre développement.

Grâce à sa connaissance approfondie de la réglementation et de la dynamique du marché, ainsi qu’à de nombreux cas de réussite, VVR Medical aide les entreprises à franchir les étapes de l’entrée et de l’établissement, garantissant ainsi une transition en douceur vers ce marché prometteur. Le voyage peut être semé d’embûches, mais les bénéfices de l’expansion de la Chine dans ce domaine en plein essor sont prometteurs. Le moment est venu d’élaborer une stratégie et de se lancer dans une aventure qui non seulement élèvera les normes de santé dans le monde entier, mais propulsera également votre entreprise sur le devant de la scène internationale.

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New Tech Applied in China’s Healthcare Industry

Le 24 août dernier, Irénée Robin, directeur et co-fondateur de VVR Medical a participé à la table ronde « New Tech Applied In China’s Healthcare Industry » organisée par La French Tech Shanghai.

Cet article revient sur l’intervention d’Irénée Robin, au cours de laquelle il a partagé des conseils pour les entreprises du domaine des technologies médicales souhaitant réussir sur le marché chinois. Passionné et au fait des dernières avancées dans le domaine, Irénée a également évoqué les innovations récentes qui ont retenu son attention, suscitant fascination et espoir telle que de l’utilisation de logiciels de réalité virtuelle en substitution des médicaments, pour soigner des pathologies du système nerveux central (tels que les douleurs ou certaines phobies) !

Au cours de son intervention, Irénée Robin a d’abord partagé son expertise concernant le processus d’enregistrement réglementaire des produits très innovants. Il a expliqué comment interagir avec le régulateur chinois (NMPA) lorsqu’il s’agit de soumettre des demandes d’autorisation de mise sur le marché de technologies encore inconnues de ce dernier. Dans ce cas, les procédures sont longues et complexes et la demande d’autorisation n’est pas toujours validée, c’est pourquoi il est conseillé de s’appuyer sur l’aide d’un expert pour maximiser les chances de succès.

Irénée Robin a ensuite insisté sur la nécessité de réaliser une évaluation de sa technologie avant d’initier les procédures d’enregistrement en vue de la mise en place d’un réseau de distribution sur le marché chinois. Selon notre expert, il est essentiel de confronter son produit ou son service à une série de questions qui permettront de déterminer l’adéquation de celui-ci avec les besoins du secteur médical chinois et la pertinence de son intégration au marché local. En effet, avant de se lancer, il est crucial de s’assurer que son produit ou service apporte une amélioration dans la résolution d’un problème précis :

  • Pour les patients (amélioration du standard de soins, de diagnostic, de prophylaxie…)
  • Pour les praticiens (facilitation ou accélération du diagnostic, ambulatoire vs. Hospitalisation, aide à la décision clinique…)
  • Pour les hôpitaux (diminution des coûts, facilitation des flux de patients, synergies entre départements, meilleure utilisation des dispensaires locaux ou « points of care » …)
  • Pour résoudre un problème de santé publique important pour le gouvernement chinois (Progression du home care, impact médico-économique…)

Dans certains cas, la technologie peut apporter des solutions ou des améliorations à différents niveaux. Par exemple, une innovation permettant de diagnostiquer précocement certaines maladies constitue à la fois une avancée pour les patients en permettant des traitements moins lourds. Elle permet également d’alléger le coût et la durée de la prise en charge pour les hôpitaux. Enfin, elle peut faire reculer la prévalence de certaines pathologies au sein de la population pour finalement permettre au système médical de réaliser des économies à l’échelle nationale.

Selon Irénée Robin, il est indispensable d’être capable de qualifier voire mesurer précisément l’impact que le produit ou service aura dans la résolution du problème, et d’identifier à qui cette amélioration profitera. De plus, il ne s’agit pas seulement d’introduire de la technologie dans le soin pour être considéré comme une innovation médicale. En effet, c’est en combinant technologie, compétences cliniques et compréhension des parcours de soins (souvent complexes et impossibles à modifier en profondeur) que les produits et services acquièrent une valeur ajoutée et révolutionnent le secteur médical. L’innovation médicale doit répondre aux attentes réelles des patients et des praticiens. Irénée Robin conclue en rappelant que les plus grands succès en health tech s’obtiennent en s’appuyant sur des équipes pluridisciplinaires dans toutes les phases de recherche et développement.

En résumé, avant de se lancer sur le marché chinois, il faut :

  1. Identifier et qualifier précisément l’amélioration qu’apportera le produit ou le service dans le secteur de la santé chinois ;
  2. Prendre en compte l’ensemble de la chaine de soins et s’appuyer sur une équipe interdisciplinaire dès la phase de développement ;
  3. Accompagner l’innovation d’une connaissance du fonctionnement du monde médical et des enjeux propres au secteur en Chine.

Dans la seconde partie de son intervention, Irénée Robin a analysé plus précisément les collaborations franco-chinoises dans le domaine de la health tech. Selon lui, la stratégie à privilégier pour réussir sur le marché chinois serait de conserver toute la recherche et le développement de l’innovation produit en France, et de s’appuyer sur les forces d’un partenaire chinois dans la mise à l’échelle et la commercialisation sur toute la Chine des innovations développées hors Chine. « Les meilleures alliances sont celles qui jouent sur les forces des partenaires, et non celles qui visent à corriger leurs faiblesses ».

Vous avez un projet?

Irénée Robin et l’équipe d’experts de VVR Medical peuvent vous conseiller et vous aider à réaliser votre projet de développement en Chine. Contactez-nous!

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Talk : New Tech applied in China’s Heathcare industry

On the 24th of August between 18:30 and 21:00 (CT) in Shanghai, organized by La French Tech Shanghai

Irénée Robin, founder and partner of VVR Medical, will take part of a talk organized by the La French Tech Shanghai.

  • Restiter to join us in Shanghai (Campus France, 5F Building D6, HuaXin Tech Park, 39 Hongcao Road, Xuhui District) the 24th of August, at 18:30 : https://www.wjx.top/vm/tn4j0YT.aspx
Are you interested in the opportunities offered by the China’s heathcare industry ?
Irénée Robin and the dedicated team of VVR Medical experts can advise your company and help you realize your development project in China.
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Interview of Irénée Robin, Managing Partner at VVR Medical, on Radio Television HK

[PODCAST] Medical innovations in China Mainland and HK : The opportunities for foreign companies

Irénée Robin, Managing Partner at VVR Medical was present during the third Asia Summit on Global Health, in Hong Kong which brought stakeholders from healthcare experts to renowned academia and influential business leaders to explore opportunities in the healthcare sector.

Irénée Robin was one of the speakers at a session focused on medical technology at the event. On this occasion, he was invited by Radio Television Hong Kong for an interview about opportunities in the healthcare sector in Mainland China and HK.

 

You can listen to the replay of this interview by following this link:

First of all, how healthy would you say the level of investments into the healthcare industry in Mainland China is?

In Mainland China I tend to think that it’s never enough […] but it is increasing and it’s refocusing. The Chinese government has made the health of their own population a priority that they want to address with their own solutions. This strategy is leading to the integration of the whole manufacturing line of every medical device, product, medicine that is needed. In the healthcare sector, the cheapest consumable to the highest end implant tends to be made in China by China, for the Chinese people. This integration will actually generate affordability and eventually decrease the amount of investment or the amount of money needed to take care of the people.

These market dynamics are observable mainly in the day-to-day problems of healthcare in China, but not necessarily in Innovation scope.

About innovation, what are the sort of innovations you’re talking about here and where do we stand with those and what needs to happen to make those go ahead?

Over the past 20 years, China has been very good at scaling up and enabling as many people as possible to have access to basic healthcare. […] During the pandemic, especially the early stage, we saw a few of returnees having spent between 10 and 20 years in Europe or in the US, coming back to China to bring overseas innovation and trying to incubate it in China as well. Now the innovation mindset and spirit is strongly on the rise in China. A growing number of biotech and metric industries and companies are resolutely committed to innovation and introducing new technologies to the Chinese market. China’s gap in medical innovation is closing, but the challenge remains for foreign innovators wishing to penetrate the market. Indeed, this can prove difficult as the government focuses on mass production in China for the Chinese at the expense of innovative products which may not have the best commercial opportunities on the market […]. In this context, I work daily to find a way for the most innovative products to find their place on the Chinese market.

About some of these innovations, what are the most exciting developments that you’re keeping a watch on more broadly around medical technology […]?

Overall, everything related to AI and big data is at the forefront right now. But if we focus on China, […] big data innovations related to diagnosing diseases at an early stage are particularly interesting. A lot of China’s health problems could be solved by earlier diagnosis, but this is complicated by the sheer numbers of people and the way healthcare changes are organized, so the prospects for diagnostic innovations in the Chinese market are promising for years to come.

[…] You mentioned a lot about how China is very much focused on making things domestically and having them available domestically. Are there still opportunities for foreign enterprises to get involved in the sector?

A lot. […] For newcomers, if it’s a company offering an innovation that can solve a patient problem, a doctor problem, a problem related to hospital operations, or a problem related to health economics, or several of these problems at once, there’s a way forward. […] In addition, the legislation applicable in China may in some cases give an advantage to certain imported products: their registration may be faster than that of domestic products. Moreover, if products are registered as import devices, the company can make full use of its data abroad, including clinical data, which is not possible if the product is registered domestically.

Let’s take our attention now to Hong Kong and the greater Bay Area. […] What role do you think Hong Kong in the greater Bay Area can play in helping save the mainland companies’ expansion to a more global market?

Hong Kong has many roles to play for the medical industry. […] In terms of culture and relationships, Hong Kongese have a good understanding of the players and how the mainland market works. As a result, they are able to grasp the needs of Chinese companies wishing to go abroad. They can provide this cultural insight, but also in terms of investment capacity and the ability to mobilize local financial resources to ensure that these companies have a very strong and solid international arm.

 

You are interested in the opportunities offered by the Chinese Healthcare market? Irénée Robin and the dedicated team of VVR Medical experts can advise your company and help you realize your development project in China.

Contact us

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The In-Vitro Diagnostics market post-Covid in China

The Chinese In-Vitro Diagnostics market post-Covid evolution

From one-seventh (1/7) of the global market in 2018, and despite almost doubling in value (16 bn$ vs. 9bn$), the In-vitro diagnostics post-covid market of China now represents “only” one-eighth (1/8) of the global market. And indeed, this market’s YOY growth is around 20%, which is lower than the growth rates of all other major zones.

How to explain this relative “under-performance” ?

Several factors explain this relative “under-performance”. To start with, the pandemic took its toll on the IVD market evolution, as it focused the vast majority of the industry almost exclusively on Covid-19 diagnostics – thereby delaying much needed innovation in other therapeutic areas. In addition, various zero-Covid policy-related measures taken during 2020-2022 also negatively impacted the smooth development of the local IVD industry.

China’s reopening: new opportunities for foreign companies

  • However, now that China has fully reopened, the potential for the country to re-capture this growth differential is massive:
  • Diagnostics – and, in particular, early-stage confirmatory diagnostics and large-scale screening products – are still under-utilized in China compared to the rest of the world, which explains a per capita IVD consumption under 10$ compared to >60$ in the USA, 38$ in Japan and 30$ in Europe.
  • The large number of PCR testing laboratories set up during the pandemic are being converted to provide diagnostics on various kinds of targets, such as tumor precision diagnosis, reproductive genetics, birth defects, pathogen detection
  • Independent Clinical Laboratories (ICL) are on the fast rise and represent now a market size of ~4bn$ within the overall diagnostics market.
  • In main cities, following the publication of State Decree 739 in 2021, the government actively promotes the generalization of Laboratory Developed Tests (LDT), which can be viewed as China’s interpretation of the CLIA model.
  • The “Healthy China 2030” Plan sets ambitious objectives on multiple health indicators: achieving them will require strong improvements in the diagnostics area, sometimes even more so than in therapeutics.

The Chinese diagnostics market: growth perspectives

Therefore, VVR Medical considers that the Chinese diagnostics market will grow faster than the overall healthcare sector in the coming years, thus providing European Dx innovators with unique international development opportunities.
We estimate a ~25% YOY growth of the Chinese diagnostics market throughout the period 2023-2030.

Key Takeways from the China Association of Clinical Laboratory Practice (CACLP) Exhibition 2023

Integration, high throughput, instantaneous results, affordability, and portability are the key development trends of products and technologies in China IVD Market. This was clearly illustrated during the CACLP Exhibition 2023 (27-29 May, Nanchang) where a significant amount of new product offerings – particularly from up-and-coming Chinese companies rather than the historical big players such as Roche, Abbott or Siemens – revolved around the following domains:

  • Flux Management: Affordable Laboratory Automation Systems (LAS) aimed at second-tier hospitals, with such a variety of products and providers that we believe it will eventually lead to industry restructuring and concentration.
  • Last Mile Healthcare: POCT diagnostics, with products that tick the affordability box but, so far, in our opinion, lack the capabilities for integration and have not reached the desired level of portability yet;
  • Highly affordable NGS: democratization of sequencing via home-grown, China-specific equipment and technologies such as the AXP100 from Shenzhen-based AxBio.

 

Article written by Irénée Robin, Co-founder & Managing Partner at VVR Medical

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China, dream or real market opportunity for French startups?

Last 4th April 2023, on the occasion of the SNITEM Start-up day, Irénée Robin, founder and partner of VVR Medical, expert of Chinese health market, was with the MEDICALLIANS experts from UK – Germany – France – USA – Middle East, to present the development opportunities for french stratups in the main international health markets.

During a workshop focusing on China, Irénée Robin, founder and partner of VVR Medical shared his vision of the Chinese healthcare market, and the business strategies for French startups and companies.

Here are the key takeaways from his speech:

China is (still) striving for the world’s best & cheapest healthcare

The pandemic delayed the process and highlighted structural issues…

  • Suboptimal use of all components of the healthcare chain
  • Deficits in early diagnosis and treatment

…but has triggered changes providing new opportunities

  • Generalization of smart hospital systems
  • Clear vision of Big Data in healthcare

The triptych to achieve this objective in MedTech: Innovation, Scaleability, Affordability

  • Accelerated regulatory proceedings
  • Volume-Based Procurement
  • Promotion of local manufacturing

Those changes raise new questions and challenges for MedTech innovators

  • Market access, distribution channels
  • Realistic bottom line, value chain
  • IP protection, local partners

VVR Medical experts can help you !
Click here to contact Irénée Robin, Co-Founder & Managing Partner at VVR Medical, member of MEDICALLIANS.

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